Clinical Development Senior Manager

Job Title

Job Description

Job Responsibilities:
Manages talent across the team while driving employee selection performance management compensation management career development and ensuring effective operational management.
Setting clear goals and expectations providing regular feedback and recognition direction and goals/KPIs for the team to ensure operational excellence.
Ensuring open and effective communication cultivate a positive and motivating work environment to foster engagement development and retention.
Oversees the recruitment hiring onboarding and managing the performance of Clinical Development Scientists ensuring they have the necessary skills and knowledge to meet project objectives and regulatory requirements.
Coaches and guides newly hired and existing Clinical Development Scientists enabling a culture of continuous learning and development and enhancing the teams capability to produce compliant and high-quality clinical documentation.
Evaluates and recognizes opportunities for process improvements in clinical development leading initiatives to streamline operations enhance organizational capabilities and drive innovation in evidence generation and dissemination.
Represents the clinical development team in interactions with senior management or executive levels providing strategic guidance and insights based on in-depth analysis of organizational objectives and performance data to inform decision-making and drive clinical development success.
Aligns clinical development strategies with organizational goals by collaborating with senior leadership and key stakeholders ensuring that clinical initiatives support broader business objectives and regulatory requirements.
Champions best practices and global regulatory standards for clinical development activities including product development clinical evaluations clinical trials and safety assessments to secure regulatory approvals and fulfill post-market requirements.
Conducts relationship management activities within the Clinical and Medical functions and cross-functionally with Regulatory Risk Management Engineering Marketing Quality HEMAR Biostatistics and Data Management to achieve project objectives.
Develops and implements solutions to complex clinical development problems utilizing ingenuity and creativity to ensure consistency with organizational objectives and compliance with regulatory standards.
Delegates tasks and responsibilities strategically optimizing resource allocation to support the execution of clinical development plans and ensuring that project timelines and deliverables are met while managing costs effectively.
Guides the production of clean clear concise and compliant clinical documentation through expert-level use of standard software tools and systems and by applying internal procedures and external regulatory standards.
Leads initiatives to improve clinical and economic research processes design principles and execution for evidence generation partnering effectively with business leaders to drive innovation and efficiency.

Minimum required Education:
Bachelors/ Masters Degree in Science or equivalent.

Minimum required Experience:
Minimum 5 years of experience with Bachelors OR Masters in areas such as Clinical Development Evaluation or Innovation or equivalent.


Preferred Experience:
8-10 years of experience in Clinical Development Evaluation or Innovation or equivalent.
5 years of management experience.


Preferred Skills:
Regulatory Compliance
Data Analysis & Interpretation
Continuous Improvement
Business Acumen
People Management
Project Management
Risk Management
Strategic Planning
KPI Management
Document Auditing
Medical Terminology
Regulatory Requirements
Clinical Evaluation Methodologies
Clinical Evidence Generation Strategy